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Braeburn Pharmaceuticals - Probuphine

Gold Stevie Award Winner 2016, Click to Enter The 2017 American Business Awards

Company: Braeburn Pharmaceuticals, Princeton, NJ
Entry Submitted By: Coltrin & Associates, Inc
Company Description: Braeburn Pharmaceuticals, a commercial stage pharmaceutical company, focuses on novel, long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions,
Nomination Category: Product & Service Awards Categories
Nomination Sub Category: Best New Product or Service of the Year - Consumer Products

Nomination Title: Probuphine: A Tiny Six Month Implant Innovates Treatment for America’s Opioid Epidemic

Describe for the judges the nominated product or service, including its features, functions, benefits, and performance to date (up to 525 words). Include in this section the date since the beginning of July last year on which the product or service was introduced to the marketplace:

With an opioid epidemic killing 78 people a day, Probuphine, the first six-month implant to treat opioid dependence, received FDA approval May 26th, 2016.

The media has declared it a ‘game changer.’

Why? There has been little innovation in the last 15 years for the treatment of opioid dependence. The two main medicines, Methadone, a liquid and Buprenorphine a pill or a film, have limitations for patients.

With Methadone, a patient has to go to a clinic daily, wait in line, receive and take their medicine while being observed, leave and come back tomorrow.

With Buprenorphine a patient has to remember to take a pill or place a film in their mouth daily. They may run out , forget to take it, and pills may lead to accidental pediatric exposure. For opioid dependence, one relapse can be fatal. The treatment barriers for patients are extraordinarily high.

From the FDA – “Buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis.”

Probuphine received FDA’s priority review . Its unique formulation potentially minimizes the issues of diversion and unintentional pediatric exposure occurring with oral buprenorphine. With Probuphine, physicians know patients receive their prescribed dosage for six months and are free from taking daily medication.Administered as a subdermal implant, it is anticipated that Probuphine is less likely to be stolen, diverted or accidentally ingested.

Only 17 days after FDA approval, the first opioid-dependent patients received the implant . In a rapid response approach, by the end of the 2016, approximately 3,000 healthcare providers around the country will be trained to implant this life-changing medicine. One of the clinical trial patients told NBC’s Today Show that Probuphine, “gave me my life back.”

Often fraught with moral judgement along with societal ignorance , the intersection of stigma and innovation is not where business spends time. The opioid epidemic is a perfect storm with a complete lack of innovation. The disease is seen as a moral failing rather than a genetically pre-disposed chronic brain disease. People with this disease are called addicts rather than patients, and told to abstain and pray , rather than seek treatment. There is a social justice solution that is grounded in science, the answer is medicine, counseling and psych-social therapies.

Probuphine is emerging as an innovative medicine at the forefront of the opioid epidemic to help improve the lives of opioid dependent patients.

Braeburn’s vision is to tackle therapeutic areas widely recognized as growing public health crises . Probuphine is the first.

Bringing an innovative six-month implant like Probuphine to doctors and patients while seeking to improve public health and social cost outcomes will have an important impact on the lives of patients.

Provide a brief biography of the person or persons who lead the team that developed the nominated new product or service (up to 125 words):

Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals has over 25 years of experience leading U.S. and global pharmaceutical development and commercialization. Millions have benefitted from the blockbuster medicines she helped bring to market including; Abilify, Glucophage and Plavix.

Braeburn’s vision is to create a new continuum of care with long-term treatments for opioid dependence, schizophrenia, and pain. The company’s robust pipeline includes seven injectable or implantable medicines that utilize proven technologies and molecules. Probuphine, Braeburn’s first commercial product, was approved in May 2016 and is the first long-acting buprenorphine implant designed to treat opioid dependence for up to six months.

Behshad’s successful career encompasses leadership positions at Otsuka Pharmaceuticals, SmithKline-Beecham and Bristol-Myers Squibb. She holds a BS Degree in Neuroscience , University of Rochester.